Merck & Co’s new human papillomavirus (HPV) vaccine could be on the market as early as next year, offering broader protection against the cancer-causing infection than its own Gardasil jab.
The company said it will be filing the experimental vaccine, currently known as V503, with US regulators this year, after an impressive performance in Phase III clinical trials.
Gardasil, which has been on the market since 2006, protects against four strains of HPV responsible for around 70% of all cervical cancers. But V503 protects against an additional five strains of the virus, which altogether cause 90% of all cervical cancer cases.
The pivotal Phase III study (Protocol 001) evaluated the efficacy, safety and immunogenicity of V503 compared to Gardasil in 16-26-year old females.
Data showed a 96.7% reduction in the combined incidence of high-grade cervical/vulvar/vaginal disease caused by HPV types 31, 33, 45, 52, 58, and a 97.1% reduction in the combined incidence of cervical/vulvar/vaginal disease of any grade.
Merck is hoping that, given its broader protection, healthcare providers will switch from Gardasil to V503 in the vaccination programmes, and analysts reportedly expect that the latter will eventually rake in sales of over $1 billion.
Two-dose Cervarix?
Meanwhile, GlaxoSmithKline unveiled results of a Phase III study of its HPV vaccine, Cervarix (Human papillomavirus types 16 and 18 vaccine, recombinant), which showed that two doses of the jab in girls aged nine to 14 years provide an immunogenicity matching the currently licensed three-dose schedule in 15 to 25 year olds.
The vaccine is currently only approved in the EU for use in females from the age of nine years via a three-dose schedule, but the drugmaker has submitted a variation to the current Marketing Authorisation seeking to add a two-dose schedule in girls aged nine to 14 years old for the prevention of premalignant genital lesions and cervical cancer causally related to certain oncogenic HPV types.
